NCT01398241已完成1 期
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, 18 to 45 years of age,
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
- •Female subjects must be surgically sterile or post-menopausal
- •Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose
排除标准
- •History or evidence of any clinically significant disease or disorder
- •Administration of an investigational drug or device within 3 months prior to dosing on Day 1
- •Positive for hepatitis B, hepatitis C or HIV at screening
- •Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing
研究组 & 干预措施
Active
Experimental
干预措施: RO5267683 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 14 weeks
次要结局
- Lipid levels in the blood(14 weeks)
- Pharmacokinetics: Plasma concentrations(14 weeks)
- Pharmacokinetics: Urine concentrations(4 weeks)
研究者
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